
Laws needed to protect patients from stem cell clinics' exaggerated claims: study
Published Wednesday December 3rd, 2008


TORONTO - Canadians should be wary of foreign clinics that use websites to promote stem cell therapies for a wide range of medical conditions, researchers warn, pointing to a dearth of scientific evidence to support claims the treatments work.
A study by the University of Alberta analyzed the services advertised online by 19 clinics in such countries as China, Mexico and Russia, which portrayed their so-called stem cell treatments as safe and effective, with little risk to patients.
But the researchers say the medical literature does not support the clinics' assertions about many of the therapies, which are aimed at treating everything from multiple sclerosis and Alzheimer's to spinal cord injuries and heart disease.
"Canadians should be very skeptical of these services," said principal author Tim Caulfield, a professor of public health sciences and law at the Edmonton university. "If it sounds too good to be true, it probably is."
"Stem cell research holds great, great promise - but many of the services offered by these clinics simply aren't ready for clinical use," Caulfield said in an email interview from Dhaka, Bangladesh, where he was attending a conference.
Stem cells are the body's building blocks, giving rise to all its different tissue types. They also have the ability to continually reproduce themselves. Scientists hope they can one day be harnessed to repair or regenerate diseased organs, damaged brain cells and other tissues.
Canada has well-established regulations regarding the use of therapies that incorporate stem cells, Caulfield said. Only a few have actually been proven safe and effective - for example, stem cells from bone marrow to treat leukemia - and are approved for use in patients.
But some clinics pitching their stem cell wares on the Internet say they can help where traditional, evidence-based medicine has failed. For instance, one Chinese clinic says it can help patients with a wide variety of neurological conditions, such as Parkinson's disease, recover some brain function with stem cells injected into the brain or the spinal fluid.
Such claims are not backed up by research, said Caulfield and colleagues, whose paper is published in the December issue of the journal Cell Stem Cell. However, they cautioned that their general findings can't be applied to the claims of any individual clinic.
"I think all the services that involve serious diseases have the potential to exploit the highly vulnerable," he said. "There are websites where parents are trying to raise funds to send extremely sick or disabled kids to one of these clinics. (It's) extremely sad."
Toronto researcher James Till, who with colleague Dr. Ernest McCulloch first identified the formation of stem cells in 1961, said an international body is needed to regulate clinics marketing improperly tested therapies.
"The problem of 'stem cell tourism' ... is a genuine and serious one," said Till, who lauded the Edmonton researchers for showing "so clearly the kind of online marketing that's going on."
Dr. George Daley, past-president of the International Society of Stem Cell Researchers, called the research a "scholarly substantiation of our concern."
The study is accompanied in the journal by a report from the society on new guidelines for translating basic stem cell research into fully tested applications for patients. The organization also plans to post an educational handbook for patients on its website: www.isscr.org .
"There's a difference between legitimate clinical research and the marketing of commercial, unproven stem cell therapies, which is what we're seeing through the web," said Daley, a hematologist-oncologist and researcher at Children's Hospital Boston.
Canada, the United States and European countries have strict regulations governing stem cell use, he said.
"There are certain standards that need to be upheld to ensure that patients are protected, that at least they know what they're getting into and that they're not being subjected to unproven therapies and being charged for it."
In the University of Alberta study, the authors said that of four clinic websites that mentioned cost, the average out-of-pocket price for treatment was $21,500.
Daley said patients who have called him about treatment at foreign clinics talked of charges that ran to "tens of thousands of dollars."
He stressed that patients who choose to seek help from these practitioners could be putting their health in serious jeopardy.
"This is potentially very dangerous," said Daley, adding that some of the ways clinics are using stem cells make him "shudder."
"We don't really know the behaviour of most stem cell products ... So I'm really worried about patients and I'm also worried about the (stem cell) field because the field is in a tender, fledgling state. It's just getting started."
"And stem cells have had so much attention from the media, there's a high risk that patients will believe that stem cells are much more therapeutically established than they are."


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